Non-fluoride containing dietary supplement toothpaste and methods of using the same

ABSTRACT

A non-fluoride containing toothpaste enriched with at least one dietary supplement. The non-fluoride containing toothpaste comprising a dentally acceptable oral vehicle containing a sufficient amount of thickening agent to impart a pasty consistency; and at least one dietary supplement wherein a serving size portion of the non-fluoride containing toothpaste contains more than about 2 percent of the reference daily intake (RDI) of the dietary supplement.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a divisional of co-pending U.S. patentapplication Ser. No. 12/454,674 filed May 21, 2009 the entire contentsof which are incorporated by reference herein.

TECHNICAL FIELD

The present disclosure generally relates to oral hygiene products, andmore particularly to oral hygiene products containing dietarysupplements, and methods of use thereof.

BACKGROUND

Oral hygiene products, such as toothpastes, have been in use for manyyears. Toothpastes generally include an abrasive material which isdispersed in a gel or paste base. Abrasives remove stains and plaque, aswell as polish teeth. Common abrasives include calcium phosphates,alumina, calcium carbonate, and silica. Toothpaste must be abrasiveenough to remove plaque and stains, but should not be so abrasive as todamage tooth enamel.

Fluoride is typically added to toothpaste in order to reduce toothdecay. In particular, fluoride incorporates itself into tooth enamel tomake teeth more resistant to acids produced by plaque bacteria, as wellas acids found in fruit juices, soda and certain foods. Indeed,toothpastes containing fluoride hardens tooth enamel to make the entiretooth structure more resistant to decay and promote remineralization,which aids in repairing early decay. In toothpaste, fluoride is commonlyfound in the form of sodium monofluorophosphate, stannous fluoride, orsodium fluoride. Notably, due to the toxicity of fluoride, the Food andDrug Administration (FDA) regards any toothpaste containing fluoride asa drug. Accordingly, the FDA requires a warning on the label of anytoothpaste containing fluoride stating “If you accidentally swallow morethan used for brushing, seek professional help or contact a poisoncontrol center immediately.” Moreover, the American Dental Association(ADA) requires that toothpaste manufacturers include the followinglanguage on all ADA-Accepted toothpastes containing fluoride: “Do notswallow. Use only a pea-sized amount for children under six. To preventswallowing, children under six years of age should be supervised in theuse of toothpaste.” Clearly, toothpastes containing fluoride are notintended to, and should not, be swallowed.

Detergents may also be added to toothpastes to aid in cleaning. Forexample, detergents may be added to create a foaming action. Foamprevents toothpaste from dribbling out one's mouth during brushing. SLS(sodium lauryl sulfate) is a commonly used detergent.

Toothpastes may also include other ingredients such as, for example,humectants to prevent toothpaste from drying out, thickeners andpreservatives to prevent the growth of microorganisms, flavoring agents,sweeteners, and coloring agents.

At least some portion of a serving size of toothpaste is swallowedduring brushing, even if not intended. The portion of the toothpastewhich is swallowed, including any dietary ingredient(s) therein, isdigested in the gastrointestinal tract. Known toothpastes which includevitamins and/or minerals, however, fail to provide the vitamins and/orminerals such as, B-complex of vitamins, Vitamin C, and calcium, forexample, in an amount sufficient to be considered a “significant source”of the dietary supplement(s) included therein.

The term “dietary supplement” was defined in the Dietary SupplementHealth and Education Act (DSHEA) of 1994. In short, a dietary supplementis a product taken orally that contains a dietary ingredient intended tosupplement the diet. The dietary ingredients may include, for example,vitamins, minerals, herbs or other botanicals, amino acids, andsubstances such as enzymes, organ tissues, glandulars, and metabolites.Dietary supplements can also be extracts or concentrates, and may befound in many forms such as tablets, capsules, softgels, gelcaps,liquids, or powders. The DSHEA places dietary supplements in a specialcategory under the general umbrella of foods, not drugs. In particular,if a product contains less than 2 percent of the reference daily intake(RDI) of a given dietary supplement, that product is not a “significantsource” of that dietary supplement.

Therefore, what is needed on the market today is a toothpaste thatprovides a significant source of at least one dietary supplement, suchas a vitamin and/or a mineral and does not include fluoride. That is, anon-fluoride toothpaste containing more than 2 percent of the referencedaily intake (RDI) of a given dietary supplement that is safe to swallowand supplements the diet of a mammal when ingested is needed on themarket today. The present invention provides such toothpaste and isfurther described in the sections below.

SUMMARY OF THE INVENTION

The present invention provides a non-fluoride containing toothpaste thatis a significant source of at least one dietary supplement, such as avitamin and/or a mineral; and a method of use therefor. In particular,the non-fluoride containing toothpaste of the present invention isformulated so that it does not include fluoride and therefore is notconsidered to be a drug under classifications set by the Food and DrugAdministration (FDA). Desirably, the non-fluoride containing toothpasteis safe to swallow. Most desirably, the non-fluoride containingtoothpaste contains at least one dietary supplement that when ingestedsupplements the diet of a mammal.

In one embodiment, a non-fluoride containing toothpaste enriched with atleast one dietary supplement comprises a gum base, a thickening agent,at least one dietary supplement selected from the group consisting ofvitamin B1, vitamin B6, vitamin A, vitamin D3, vitamin E, niacinamide,vitamin B12, D-calcium pantothenate and mixtures thereof. In additionthe non-fluoride toothpaste also comprises at least one componentselected from the group consisting of sodium selanate, manganesechloride, zinc lactate, magnesium sulfate, sea salt, tetrasodiumpyrophosphate and mixtures thereof. The non-fluoride containingtoothpaste may further comprise a preservative and/or a flavoring agent.

In another embodiment of the present invention, a non-fluoridecontaining toothpaste enriched with at least one dietary supplement isprovided comprising a gum base (A); a component (8) comprising at leastone component selected from the group consisting of sodium saccharin,EDTA, sodium benzoate, stevia, xylitol, a polymer of ethylene oxidegenerally having the formula H(OCH₂CH₂)_(n)OH wherein n has an averagenumber of about 8 (PEG-8) and mixtures thereof; a component (C)comprising at least one component selected from the group consisting of:glycerin, propylparaben, titanium dioxide, sorbitol, and mixturesthereof; a component (D) comprising at least one component selected fromthe group consisting of: vitamin B1, vitamin B6, vitamin A, vitamin D3,vitamin E, niacinamide, vitamin B12, D-calcium pantothenate, andmixtures thereof; a component (E) comprising at least one componentselected from the group consisting of: sodium selanate, manganesechloride, zinc lactate, magnesium sulfate, sea salt, tetrasodiumpyrophosphate, and mixtures thereof; a component (F) comprising at leastone component selected from the group consisting of a precipitatedamorphous silica having an average particle size of about 8.0 microns toabout 11.0 microns known as Zeodent® 113 available from J.M. HuberCorporation, Dicalcium phosphate dihydrate, a precipitated amorphoussilica having an average particle size of about 11.0 microns to about14.0 microns known as Zeodent® 165 available from J.M. HuberCorporation, and mixtures thereof; and a component (G) comprising atleast one component selected from the group consisting of naturalspearmint oil, sodium lauryl sulfate, and mixtures thereof.

In one particular embodiment of the present invention, a non-fluoridecontaining toothpaste enriched with at least one dietary supplement isprovided, as described above, further comprising pigmented and/ornon-pigmented beads containing vitamins and/or minerals. As such, thetoothpaste of the present invention contains vitamins and minerals asingredients in the paste of the final toothpaste product, as well asbeads which contain additional vitamins and/or minerals. By providingvitamins and/or minerals in beads in addition to the vitamins andminerals included as ingredients in the paste, an amount of vitaminsand/or minerals may be provided that exceeds the amount of vitaminsand/or minerals that can be included as ingredients in the finaltoothpaste product without precipitation from the toothpaste. Indeed,only a certain amount of dietary supplements, such as vitamins and/orminerals, may be incorporated as ingredients in the paste of the finaltoothpaste product without rendering the final toothpaste productinsufficient as a toothpaste. For example, if the amount of vitaminsand/or minerals incorporated as ingredients in the paste of the finaltoothpaste product exceeds a certain threshold, the vitamins and/orminerals may precipitate out of the paste, may become too runny or mayhave a foul taste and/or smell. Indeed, the degradation of certainvitamins and minerals has been found to cause discoloration because thedegradation products produced by the exposure to air, for example, are adifferent color than the original compound. Therefore, the toothpaste ofthe present invention provides dietary supplements, such as vitaminsand/or minerals, in beads, in addition to the vitamins and mineralsincluded as ingredients in the paste of the final toothpaste product soas to provide a significant source of dietary supplement(s) wheningested.

Furthermore, providing dietary supplements, such as vitamins and/orminerals, in beads, as further discussed hereinbelow, can prevent suchdietary supplements from being directly absorbed through the mucusmembranes in the mouth, therefore allowing more of the dietarysupplements to be digested in the gastrointestinal tract. Moreover,providing dietary supplements, such as vitamins and/or minerals, inbeads can prevent such dietary supplements from being degraded in theacidic environment of the stomach, for example, thus allowing thevitamins and minerals to be absorbed in the gastrointestinal tract.

In one embodiment of the present invention, the beads containing thedietary supplement(s), such as vitamins and/or minerals, are comprisedof a mixture of at least two components selected from the groupconsisting of: mannitol, cellulose, and hydroxypropyl methylcellulose.In another embodiment, the beads containing the dietary supplement(s)further comprises custom pigments and custom additives such as, herbs,botanicals, and flavorings.

The term “serving” or “serving size” shall be understood herein to meanan amount of food customarily consumed per eating occasion by persons 4years of age or older which is expressed in a common household measurethat is appropriate to the food. When the food is specially formulatedor processed for use by infants or by toddlers, a “serving” or “servingsize” means an amount of food customarily consumed per eating occasionby infants up to 12 months of age or by children 1 through 3 years ofage, respectively. For example, a serving size of the present inventionis equivalent to about a 1-inch strip on a standard toothbrush, which isabout 1.0 g to 2.5 g of which at least a portion is ingested eitherdirectly or over a short period of time as residue that remains in themouth after brushing.

The term “dietary ingredient” shall be understood herein to includevitamins, minerals, herbs or other botanicals, amino acids, andsubstances such as enzymes, and metabolites.

The term “dietary supplement” shall be understood herein to include anyproduct taken by mouth that contains a “dietary ingredient,” as definedabove, which is intended to supplement the diet by ingestion. Dietarysupplements can be extracts or concentrates, and may be found in manyforms such as beads, pastes, tablets, capsules, softgels, gelcaps,liquids, or powders.

The term “reference daily intake” (RDI) shall be understood herein torefer to the estimated daily intake values for vitamins, minerals, andother dietary ingredients established by the FDA. For example, the RDIfor vitamin B1 is about 1.1 mg; the RDI for vitamin B6 is about 2.0 mg;the RDI for vitamin A is about 5,000 International Units (IU); the RDIfor vitamin D3 is about 400 IU; the RDI for vitamin E is about 30 IU;the RDI for niacinamide is about 18 mg; the RDI for vitamin B12 is about6 micrograms (μg); the RDI for D-calcium pantothenate is about 10.0 mg;the RDI for sodium selanate is about 70 μg; the RDI for zinc lactate isabout 15 mg; the RDI for magnesium sulfate is about 400 mg; and the RDIfor sea salt is about 2300 mg.

The expression “significant source,” when referring to a productincluding at least one dietary supplement, shall be understood to meanthat the product includes at least 2% of the RDI for the dietarysupplement(s) included therein.

The term “beads” shall be understood herein to include any substancesthat are capable of entrapping a material within the substance to form abarrier between the outside medium and the entrapped material.

The term “toothpaste” shall be understood herein to mean a non-fluoridecontaining composition.

The term PEG-8 is a polymer of ethylene oxide generally having theformula H(OCH₂CH₂)_(n)OH wherein n has an average number of about 8 asdefined in CTFA International Cosmetic ingredient Dictionary, 4¹edition, published by The Cosmetic, Toiletry, and Fragrance AssociationWashington, D.C.

Zeodent® 113 is a precipitated amorphous silica having an averageparticle size of about 8.0 microns to about 11.0 microns known asZeodent® 113 available from J.M. Huber Corporation used as a thickeningagent and/or a dental abrasive.

Zeodent® 165 is a precipitated amorphous silica having an averageparticle size of about 11.0 microns to about 14.0 microns known asZeodent® 113 available from J.M. Huber Corporation used as a thickeningagent and/or a dental abrasive.

EDTA is a widely used acronym for the chemical compound ethylene diaminetetra acetic acid. EDTA is a polyamino carboxylic acid with the formula[CH₂N(CH₂CO₂H)₂]₂. This colorless, water-soluble solid produced on alarge scale for many applications, Its prominence as a chelating agentarises from its ability to “sequester” di- and tricationic metal ionssuch as Ca²⁺ and Fe³⁺, After being bound by EDTA, metal ions remain insolution but exhibit diminished reactivity.

The above-disclosed embodiments of the present invention are furtherdescribed in greater detail in the Detailed Description of the Inventiondirectly following.

DETAILED DESCRIPTION OF THE INVENTION

The present invention may be understood more readily by reference to thefollowing detailed description of the present invention, which forms apart of this disclosure. It is to be understood that the presentinvention is not limited to the specific devices, methods, conditions orparameters described and/or shown herein, and that the terminology usedherein is for the purpose of describing particular embodiments by way ofexample only and is not intended to be limiting of the claimedinvention.

The carriers or excipients of the present invention may be chosen toprovide an appropriate mode of delivery, for example, solutions,colloidal dispersions, emulsions, suspensions, gels, powders, solids,and the like, and can include conventional components typicallyassociated with toothpastes, and the like. Carriers suitable for thepreparation of components of the present invention are well known in theart. Their selection will depend on secondary considerations like taste,cost, shelf stability and the like.

In one embodiment of the present invention, a non-fluoride containingtoothpaste enriched with at least one dietary supplement comprising agum base, a thickening agent, at least one component selected from thegroup consisting of: vitamin B1, vitamin B6, vitamin A, vitamin D3,vitamin E, niacinamide, vitamin B12, D-calcium pantothenate, andmixtures thereof, and at least one component selected from the groupconsisting of: sodium selanate, manganese chloride, zinc lactate,magnesium sulfate, sea salt, tetrasodium pyrophosphate, and mixturesthereof. The non-fluoride containing toothpaste may further comprise apreservative and/or a flavoring agent. In a preferred embodiment, thetoothpaste of the present invention has a white shiny appearance.

In another embodiment of the present invention, a non-fluoridecontaining toothpaste enriched with at least one dietary supplement isprovided comprising a gum base (A); a component (B) comprising at leastone component selected from the group consisting of: sodium saccharin,EDTA, sodium benzoate, stevia, xylitol, PEG-8 and mixtures thereof; acomponent (C) comprising at least one component selected from the groupconsisting of: glycerin, propylparaben, titanium dioxide, sorbitol andmixtures thereof; a component (D) comprising at least one componentselected from the group consisting of: vitamin B1, vitamin B6, vitaminA, vitamin D3, vitamin E, niacinamide, vitamin B12, D-calciumpantothenate and mixtures thereof; a component (E) comprising at leastone component selected from the group consisting of: sodium selanate,manganese chloride, zinc lactate, magnesium sulfate, sea salt,tetrasodium pyrophosphate and mixtures thereof; a component (F)comprising at least one component selected from the group consisting of:Zeodent® 113, Dicalcium phosphate dihydrate, Zeodent® 165 and mixturesthereof; and a component (G) comprising at least one component selectedfrom the group consisting of: natural spearmint oil, sodium laurylsulfate and mixtures thereof.

Gum base (A) is included to thicken the final toothpaste product so asto result in a paste, rather than a liquid. Gum base (A) may include anygum base known in the art suitable for toothpastes including, forexample, chicle, xanthan gum, guar gum, or a polybutene. In oneembodiment of the present invention, gum base (A) is a cellulose gumsuch as carboxymethylcellulose and/or xanthan gum, or the like. Gum base(A) may be prepared by dissolving carboxymethylcellulose in hot water,adding xanthan gum and mixing well. However, it is envisioned that gumbase (A) may be produced according to any method known in the art forproducing gum bases suitable for use in toothpastes.

In yet another embodiment of the present invention, Component (B)comprises at least one component selected from the group consisting of:sodium saccharin, EDTA, sodium benzoate, stevia, xylitol, PEG-8, andmixtures thereof. Sodium saccharin, stevia, and xylitol are provided assweeteners, to improve the taste of the final toothpaste product.Xylitol is provided to reduce tooth decay by significantly decreasingplaque accumulation. EDTA is provided as a chelating agent to removetraces of metal ions which might otherwise cause dietary ingredients todeteriorate and clinically to reduce absorption of a mineral, or toincrease its excretion. PEG-8 is provided as a thickener to preventbacteria from breaking down pyrophosphates used to control tartarbuildup.

In still yet another embodiment of the present invention, the toothpasteof the present invention includes a sweetener known in the art tosweeten toothpastes, such as cyclamate, aspartame, sorbitol, andmaltitol, for example, in the place of sodium saccharin and/or steviaand/or xylitol, or the like. It is envisioned that the choice ofsweetener may depend upon, for example, the desire to use natural orartificial sweetener, the amount of sweetening desired, and the otheringredients in the toothpaste. A chelating agent, such as a citrate,tartrate, or phosphate, for example, known in the art which is suitablefor use in toothpastes is included in the place of EDTA. It isenvisioned that the chelating agent used will be selected dependingupon, for example, the amount of metal ions present. A thickener, suchas polyethylene glycol of various weights and silicate, for example,known in the art which is suitable for thickening toothpaste is includedin place of PEG-8, or the like. It is envisioned that the thickener usedwill be selected depending upon, for example, the desired consistency ofthe final toothpaste product.

In another embodiment of the present invention, described above,toothpaste comprises at least one component selected from the groupconsisting of: glycerin, propylparaben, titanium dioxide, sorbitol, andmixtures thereof. Glycerin and sorbitol are humectants which areprovided to prevent the final toothpaste product from drying outPropylparaben is provided as a preservative. Titanium dioxide is awhitener provided to whiten teeth.

In yet another embodiment of the present invention, the toothpasteincludes a humectant, such as propylene glycol, xylitol, water, forexample, known in the art which is suitable for use in toothpastes, inthe place of glycerin and/or sorbitol, or the like. It is envisionedthat the humectant used will be selected depending upon, for example,the susceptibility of the final toothpaste product to drying. Apreservative, such as sodium benzoate, methyl paraben, and ethylparaben, for example, that is known in the art to be suitable for use intoothpastes, can be included in place of propylparaben. It is envisionedthat the preservative used will be selected depending upon, for example,the ingredients in the final toothpaste product. A whitener, such asperoxide, for example, known in the art that is suitable for use intoothpastes may be included in place of titanium dioxide. It isenvisioned that the whitener used will be selected depending upon, forexample, the desired whitening effect.

The non-fluoride containing toothpaste enriched with at least onedietary supplement includes vitamins, minerals and additives that havespecific effects on the user. For example, vitamins A, D, and E promotehealthy teeth and bones; vitamin B-complexes maintain healthy skin andgums; zinc supports the immune system; minerals strengthen bones andteeth; silica whitens teeth; and xylitol prevents plaque.

In still yet another embodiment of the present invention, the toothpastecomprises at least one component selected from the group consisting of:Zeodent® 113, Dicalcium phosphate dihydrate, Zeodent® 165, and mixturesthereof. Zeodent® 113 is provided as an abrasive/polishing agent whichhelps to clean and whiten teeth. Dicalcium phosphate dihydrate isprovided as a dental polishing product to help whiten teeth. Zeodent®165 is provided both as an abrasive/polishing agent and as a thickener.

In another embodiment of the present invention described above, thetoothpaste may comprise natural spearmint oil, sodium lauryl sulfate,and mixtures thereof. Spearmint oil is provided to enhance the flavor ofthe final toothpaste product. Sodium lauryl sulfate is provided as adetergent/foaming agent.

In yet another embodiment of the present invention, the toothpastecomprises an agent known in the art that is suitable for use intoothpastes to enhance the flavor of the final toothpaste product, suchas anise. peppermint, wintergreen, clove or cinnamon oil, for example,in place of natural spearmint oil. It is envisioned that the flavoringagent used will be selected depending upon, for example, the desiredflavor of the final toothpaste product and the ingredients used. Adetergent/foaming agent known in the art, which is suitable for use intoothpastes is provided in place of sodium lauryl sulfate.

All weight percent formulations provided in this disclosure are based onthe total weight of the toothpaste.

In still yet another embodiment of the present invention, a non-fluoridecontaining toothpaste enriched with at least one dietary supplement isprovided wherein the toothpaste comprises about 0.1 to about 1.0 percentby weight of gum base; about 0.20 to about 0.40 percent by weight sodiumsaccharin; about 0.05 to about 1.5 percent by weight ethylene diaminetetraacetic acid (EDTA); about 0.20 to about 0.40 percent by weightsodium benzoate; about 0.3 to about 0.4 percent by weight stevia; about5.0 to about 7.0 percent by weight xylitol; about 0.02 to about 0.06percent by weight of a polymer of ethylene oxide generally having theformula H(OCH₂CH₂)_(n)OH wherein n has an average number of about 8;about 26.0 to about 28.0 percent by weight glycerin; about 0.05 to about0.15 percent by weight propylparaben; about 0.4 to about 0.6 percent byweight titanium dioxide; about 12.0 to about 14.0 percent by weightsorbitol; about 2.5×10⁻⁵ to about 2.5×10″⁻³ percent by weight vitaminB1; about 2.5×10⁻⁵ to about 2.5×10⁻³ percent by weight vitamin B6; about2.5×10⁻⁵ to about 2.5×10⁻³ percent by weight vitamin A; about 2.5×10⁻⁴to about 5.0×10⁻⁴ percent by weight vitamin D3; about 5.0×10⁻⁴ to about2.0×10⁻³ percent by weight vitamin E; about 0.07 to about 1.0 percent byweight niacinamide; about 2.5×10⁻⁵ to about 4×10⁵ percent by weightvitamin B12; about 0.03 to about 0.06 percent by weight D-calciumpantothenate; about 6.0×10⁻⁴ to about 9.0×10⁻⁴ percent by weight sodiumselanate; about 0.025 to about 0.04 percent by weight manganesechloride; about 0.2 to about 0.40 percent by weight zinc lactate; about0.6 to about 0.9 percent by weight magnesium sulfate; about 0.05 toabout 0.15 percent by weight sea salt; about 0.6 to about 0.8 percenttetrasodium pyrophosphate; about 4.0 to about 6.0 percent by weight of aprecipitated amorphous silica having an average particle size of about8.0 microns to about 11.0 microns; about 1.5 to about 2.0 percent byweight dicalcium phosphate dihydrate; about 8.0 to about 10 percent byweight of a precipitated amorphous silica having an average particlesize of about 8.0 microns to about 11.0 microns for abrasive and/orthickening; about 0.5 to about 1.5 percent by weight spearmint oil andabout 1.0 to about 1.5 percent by weight sodium lauryl sulfate; andwater.

The non-fluoride enriched toothpaste of the present invention mayfurther comprises about 3.0 to about 4.0 percent by weight ofpolyethylene glycol (PEG-8), about 0.4 to about 0.6 percent by weight ofpigmented beads, about 0.2 to about 0.35 percent by weight of rentinylpalmitate and cholecalciferol. The pigmented beads may be made from amixture of mannitol, cellulose, hydroxypropyl methylceliulose, and maycomprise at least one dietary supplement.

The toothpaste of the present invention may be formulated by firstdissolving component (B) in component (A) in a container to form AB. Itis envisioned that component (B) may be admixed with component (A) toform an admixture of AB. Propylparaben is dissolved in the glycerin fromcomponent (C) in another container. Next, titanium dioxide is added andmixed. The mixture Including propylparaben; glycerin, titanium dioxide,and other components of component (C), save sorbitol, is thentransferred to the container containing AB. A portion of the sorbitolsolution from component (C) is used to rinse titanium dioxide and/orglycerin from the container, and is transferred to the containercontaining AB. The remaining sorbitol solution is then added to formABC. It is envisioned that the components of ABC may be admixed to forman admixture of ABC. Next, component (0) is added to ABC, dissolved, andmixed to form ABCD. It is envisioned that each ingredient from component(D) may be added separately and mixed following the addition of eachingredient. It is also envisioned that component (D) may be admixed withABC to form an admixture of ABCD. Component (E) is added to ABCD andmixed to form ABCDE. It is envisioned that each ingredient fromcomponent (E) may be added separately and mixed following the additionof each ingredient. It is also envisioned that component (E) may beadmixed with ABCD to form an admixture of ABCDE. Next, component (F) isadded to ABCDE to form ABCDEF. The spearmint oil from component (G) isthen added to ABCDEF and mixed. Lastly, sodium lauryl sulfate is addedto the mixture of ABCDEF and spearmint oil and mixed to form ABCDEFG.ABCDEFG should be mixed gently following the addition of sodium laurylsulfate to avoid foaming. However, it is envisioned that thenon-fluoride containing toothpaste of the present invention may beproduced by any method known in the art for producing toothpaste.

The final toothpaste product may be adjusted so as to have a neutral pH.In a preferred embodiment of the present invention, the pH of the finaltoothpaste product is about 6.0 to about 7.0, preferably 6.0 to about6.5, and more preferably a pH of 6.1.

In one particular embodiment of the present invention, a non-fluoridecontaining toothpaste enriched with at least one dietary supplement isprovided, as described above, further comprising beads containing atleast one dietary supplement such as vitamins and/or minerals, Beadsused in the present invention may be available from Induchem USA, Inc.located in New York. As such, the non-fluoride containing toothpaste ofthe present invention contains vitamins and minerals as ingredients inthe paste of the final toothpaste product, as well as beads whichcontain additional vitamins and/or minerals. By providing vitaminsand/or minerals in beads in addition to the vitamins and mineralsincluded as ingredients in the paste, an amount of vitamins and/orminerals may be provided which exceeds the amount of vitamins and/orminerals which can be included as ingredients in the paste of the finaltoothpaste product alone. Indeed, only a certain amount of dietarysupplements, such as vitamins and/or minerals, may be incorporated asingredients in the paste of the final toothpaste product withoutrendering the final toothpaste product insufficient as a toothpaste. Forexample, if the amount of vitamins and/or minerals incorporated asingredients in the paste of the final toothpaste product exceeds acertain threshold, the paste may become too runny or may have a foultaste and/or smell. Indeed, the degradation of certain vitamins andminerals has been found to cause discoloration of the toothpaste becausethe degradation products produced by the exposure to air, for example,are a different color than the original compound. Therefore, thetoothpaste of the present invention provides dietary supplements, suchas vitamins and/or minerals, in beads, in addition to the vitamins andminerals included as ingredients in the paste of the final toothpasteproduct, in an amount such that the final toothpaste product is asignificant source or the dietary supplement(s) included therein.

Furthermore, it is envisioned that providing dietary supplements, suchas vitamins and/or minerals, in beads can prevent such dietarysupplements from being directly absorbed through the mucus membranes inthe mouth, therefore allowing the dietary supplements to be digested inthe gastrointestinal tract. Moreover, it is envisioned that providingdietary supplements, such as vitamins and/or minerals, in beads canprevent such dietary supplements from being degraded in the acidicenvironment of the stomach, for example, thus allowing the vitamins andminerals to be absorbed in the gastrointestinal tract.

The beads containing at least one dietary supplement also createfriction during brushing, which enhances the ability of the toothpasteto clean and maintain the aesthetics and health of teeth, thus providingbetter oral hygiene.

In one embodiment of the present invention, the beads containing thedietary supplement(s), such as vitamins and/or minerals, are comprisedof mannitol, cellulose, and hydroxypropyl methylcellulose. It isenvisioned that the beads containing the dietary supplement (s) furthercomprise custom pigments and additives. In another embodiment of thepresent invention, the beads containing the dietary supplement (s)entrap the dietary ingredient(s), pigments, and actives within themannitol, cellulose, and hydroxypropyl methylcellulose components of thebeads. As such, a dried paste which includes a matrix of the dietarysupplement (s), pigments, actives, mannitol, cellulose, andhydroxypropyl methylcellulose is produced, which, when swallowed, willrelease the dietary supplement (s) to be later absorbed in the body. Inparticular, by providing at least one dietary supplement entrappedwithin the mannitol, cellulose, and hydroxypropyl methylcellulosecomponents of the beads, the dietary supplement (s) can be graduallyreleased from the matrix, rather than released all at once, thusallowing the dietary supplement (s) to be absorbed in the body overtime.

It should be recognized that the beads containing at least one dietarysupplement of the present invention are distinguishable from beadsheretofore used in toothpastes that include at least one dietarysupplement, such as a vitamin or mineral, for example. Indeed, knowntoothpastes which include at least one dietary supplement encapsulatethe dietary supplement (s) in cellulose without other alcohols orcomponents which make the beads break instead of creating a film-likecomponent, for example. These types of encapsulated dietary supplement(s) have a glass-like shell which break to release the contained dietarysupplement(s) all at once. Indeed, because the encapsulated dietarysupplement (s) is/are released when the glass-like shell is broken,these types of encapsulated dietary supplement (s) are incapable ofreleasing the dietary supplement (s) over time and less of thevitamins/minerals are likely to be ingested as a dietary supplement.

Non-fluoride containing toothpastes of the present invention, thatinclude beads made from cellulose and other alcohols or components, andcontain at least one dietary supplement such as vitamins and/orminerals, may be produced by first dissolving component (B) in component(A) in a container to form AB. Propylparaben is dissolved in theglycerin from component (C) in another container. Next, titanium dioxideis added and mixed. The mixture including propylparaben, glycerin,titanium dioxide, and any other components of component (C), savesorbitol, is then transferred to the container containing AB. A portionof the sorbitol solution from component (C) is used to rinse titaniumdioxide and/or glycerin from the container, and is transferred to thecontainer containing AB. The remaining sorbitol solution is then addedto form ABC. Next, component (D) is added to ABC, dissolved, and mixedto form ABCD. Component (E) is added to ABCD and mixed to form ABCDE.Next, component (F) is added to ABCDE to form ABCDEF. The spearmint oilfrom component (G) is then added to ABCDEF and mixed. Next, the beadscontaining at least one dietary supplement are added to the mixture ofABCDEF and spearmint oil, and mixed gently. Lastly, sodium laurylsulfate is added and mixed to form ABCDEFG. ABCDEFG should be mixedgently following the addition of the beads containing at least onedietary supplement and/or sodium lauryl sulfate to avoid breaking thebeads and/or foaming.

In yet another embodiment, a method for delivering at least one dietarysupplement to a mammal is provided in which a dose of the toothpaste ofthe present invention, about 1 to about 2 grams, is applied to the teethof a mammal either on a toothbrush or directly. The applied toothpasteis then used to clean and/or polish the teeth of the mammal. In doingso, at least a portion of the toothpaste, which contains at least onedietary supplement, is ingested by the mammal and supplements the dietof the mammal. This method can be repeated multiple times in a 24-hourperiod and preferably is repeated at least three times in a 24-hourperiod.

It will be understood that various modifications may be made to theembodiments disclosed herein. Therefore, the above description shouldnot be construed as limiting, but merely as exemplification of thevarious embodiments. Those skilled in the art will envision othermodifications within the scope and spirit of the claims appended hereto.

1-19. (canceled)
 20. A method for delivering at least one dietarysupplement to a mammal comprising: (a) brushing the teeth of a mammalwith a non-fluoride, non-drug containing dietary supplement enrichedtoothpaste suitable for ingestion, said toothpaste comprising: adentally acceptable oral vehicle containing sufficient amount ofthickening agent to impart a pasty consistency; and a dietarysupplement, wherein a serving size amount of said toothpaste containsmore than about 2 percent of the reference daily intake (RDI) of saiddietary supplement and wherein said toothpaste is formulated so thatmultiple ingestions of at least a portion of said serving size amountprovide at least 2 percent of the RDI of the dietary supplement; and (b)ingesting at least a portion of said serving size amount of saidtoothpaste thereby supplementing the diet of said mammal.
 21. (canceled)22. (canceled)
 23. The method of claim 20, wherein said steps (a) and(b) are repeated at least three times in a 24 hour period.
 24. Themethod of claim 20 wherein the dietary supplement comprises one or moreof vitamin B1, Vitamin A, vitamin B-12, vitamin B6, vitamin D3, vitaminE, niacinamide, D-calcium pantothenate, sodium selenate, manganesechloride, and zinc lactate.
 25. The method of claim 20 wherein thedietary supplement comprises a mixture of vitamin B6, vitamin D3,vitamin E, niacinamide, D-calcium pantothenate, sodium selenate,manganese chloride and zinc lactate.
 26. The method of claim 20 whereinthe dentally acceptable oral vehicle comprises a preservative.
 27. Themethod of claim 26, wherein the preservative is selected from the groupconsisting of ethylene diamine tetraacetic acid (EDTA), propylparabenand mixtures thereof.
 28. The method of claim 20 wherein the dentallyacceptable oral vehicle comprises a flavoring agent.
 29. The method ofclaim 28 wherein said flavoring agent is selected from the groupconsisting of sodium saccharin, stevia, natural spearmint oil andmixtures thereof.
 30. The method of claim 20 wherein the dentallyacceptable oral vehicle comprises at least one component selected fromthe group consisting of a cleaning and/or polishing agent, non-fluorideanti cavity agent, toothpaste whitening agent, moisture retaining agent,foaming agent, pigment and abrasive.
 31. The method of claim 30 whereinsaid cleaning and/or polishing agent is sodium benzoate, saidnon-fluoride anti cavity agent is xylitol, said toothpaste whiteningagent is titanium dioxide, said moisture retaining agent is glycerinand/or sorbitol, said foaming agent includes sodium lauryl sulfate, andsaid abrasive is a polymer of ethylene oxide generally having theformula H(OCH₃CH₂)_(n)OH wherein n has an average number of about 8and/or precipitated amorphous silica having an average particle size ofabout 8.0 to about 14.0 microns.
 32. The method of claim 20, furthercomprising a plurality of pigmented beads dispersed throughout saidtoothpaste.
 33. The method of claim 32, wherein the pigmented beadscontain at least one dietary supplement.
 34. The method of claim 33.wherein the beads are comprised of mannitol, cellulose and hydroxypropylmethylcellulose.
 35. A method for delivering at least one dietarysupplement to a mammal comprising: (a) brushing the teeth of a mammalwith a non-fluoride, non-drug containing dietary supplement enrichedtoothpaste suitable for ingestion, said toothpaste comprising: a gumbase as component (A); a mixture of sodium saccharin, ethylene diaminetetraacetic acid (EDTA), sodium benzoate, stevia, xylitol, a polymer ofethylene oxide having the general formula H(OCH₃CH₂)_(n)OH wherein n hasan average number of about 8 and mixtures thereof as component (B); amixture of glycerin, propylparaben, titanium dioxide, sorbitol andmixtures as component (C); a mixture of vitamin B6, vitamin D3, vitaminE, niacinamide, D-calcium pantothenate as component (D); a mixture ofsodium selenate, manganese chloride, zinc lactate, magnesium sulfate,sea salt, tetrasodium pyrophosphate as component (E); precipitatedamorphous silica having an average particle size of about 8.0 to about14 microns for both abrasive and/or thickening and dicalcium phosphatedihydrate as component (F); at least one flavoring agent as component(G); and water, wherein the combination of components ABCDEFG is formedby the sequential addition of component B to component A to form thecombination AB, the addition of component C to AB to form thecombination ABC, the addition of component D to ABC to form thecombination ABCD, the addition of component E to ABCD to form thecombination ABCDE, the addition of component F to ABCDE to form thecombination ABCDEF, and the combination of component U to ABCDEF to formthe combination ABCDEFG, and wherein said toothpaste is suitable forbeing ingested wherein a serving size amount of said toothpaste containsmore than about 2 percent of a reference daily intake (RDI) of dietarysupplement, said dietary supplement comprising vitamin B6, vitamin D3,vitamin E, niacinamide, D-calcium pantothenate sodium selenate,manganese chloride, and zinc lactate, and wherein said toothpaste isformulated so that multiple ingestions of at least a portion of saidserving size amount provide at least 2 percent of the RDI of the dietarysupplement; and (b) ingesting at least a portion of said serving sizeamount of said toothpaste thereby supplementing the diet of said mammal.36. The method of claim 35 wherein component (G) is selected from thegroup consisting of natural spearmint oil, sodium lauryl sulfate, andmixtures thereof.
 36. The method of claim 35 wherein the toothpastefurther comprises about 3.0 to about 4.0 percent by weight ofpolyethylene glycol (PEG-8), about 0.4 to about 0.6 percent by weight ofpigmented beads, about 0.2 to about 0.35 percent by weight of rentinylpalmitate and cholecalciferol.
 37. The method of claim 35 furthercontaining a plurality of pigmented beads dispersed throughout saidtoothpaste.
 38. The method of claim 37, wherein the beads are comprisedof mannitol, cellulose, hydroxypropyl methylcellulose, and at least oneof vitamin B6, vitamin D3, vitamin E, niacinamide, D-calciumpantothenate sodium selenate, manganese chloride, and zinc lactate.